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临床试验/NCT06049121
NCT06049121已完成不适用

In Vivo Biofilm Accumulation on Implants With 3 Different Surfaces

Malmö University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
quantification of the biofilm

研究概览

简要总结

A frequent sequela of peri-implantitis itself, but also of its surgery, is the exposure of the implant surface to the oral environment. This moderately-rough surface with threads, when exposed to the oral environment, is difficult to clean. Therefore, in cases where the implant surface is expected to remain exposed or to be in direct contact with the peri-implant mucosa, implantoplasty has been proposed to obtain a smoother surface. A smoother surface should allow more efficient plaque control. This in vivo study aims to evaluate potential differences in terms of plaque accumulation between 3 different implant surfaces.

Ten participants will wear the removable splint carrying 2 implants of each type of surface (i.e., turned, modified, and modified treated with implantoplasty) for 3 days and they will be asked to remove it to perform their (usual) oral hygiene and immerse the device in cold-tap water. On day 3, the removable splint will be collected for analysis. The area of biofilm covering the implants will be quantified with different methods.

详细描述

The aim of this in vivo study is to evaluate potential differences in terms of plaque accumulation among 3 different implant surfaces (i.e., turned, modified, and modified treated with implantoplasty).

Splint fabrication At the first visit, a maxillary alginate impression and a gypsum cast will be produced for every participant. This cast will be used to build a removable vacuum splint, which in turn will allow to carry six implants during the study period (i.e., 2 implants of each group T, M, I). Both on the right- and left-buccal aspects of the cast, three implants (i.e., 1 implant of each group T, M, I) will be randomly allocated and secured in their position prior to making the vacuum splint. The splint will be individually trimmed and polished to provide both retention and comfort.

At the second visit, splints will be tried and, if necessary, adjusted to avoid any discomfort. Participants will be instructed in detail on how to wear and handle the splint.

At the third visit, splints will be collected and stored for analyses.

Sample size calculation The only previous study with a similar study design (Azzola et al., 2020) included only a single participant. Based on the presented data of this specific study and due to the large difference between the test and control group, a reasonable sample size calculation was not feasible. Thus, a sample size of 10 participants was arbitrarily chosen for the present study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults, > 18 years old
  • systemically healthy
  • full mouth healthy periodontal conditions
  • Exclusion Criteria
  • current pregnancy or breastfeeding
  • heavy smokers (> 10 cigarettes per day)
  • antibiotic intake in the previous 3 months
  • orthodontic appliances in the upper jaw
  • removable prosthesis in the upper jaw
  • extensive implant-supported restorations in the upper jaw
  • active carious lesions

排除标准

  • 未提供

结局指标

主要结局

quantification of the biofilm

时间窗: 3 days

Quantification with crystal violet biofilm quantification assay

次要结局

未报告次要终点

研究者

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Stavropoulos

Professor

Malmö University

研究点 (1)

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